|Publication number||US8012179 B2|
|Application number||US 11/429,816|
|Publication date||Sep 6, 2011|
|Filing date||May 8, 2006|
|Priority date||May 8, 2006|
|Also published as||US20070270836|
|Publication number||11429816, 429816, US 8012179 B2, US 8012179B2, US-B2-8012179, US8012179 B2, US8012179B2|
|Inventors||Aurelien Bruneau, Thomas Carls, Eric C. Lange, John D. Pond, Jr., Kent Anderson, Henry Bonin|
|Original Assignee||Warsaw Orthopedic, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (68), Referenced by (5), Classifications (9), Legal Events (5)|
|External Links: USPTO, USPTO Assignment, Espacenet|
Elongated connecting elements, such as rods, plates, tethers, wires, cables, and other devices have been implanted along the spinal column and connected between two or more anchors engaged between one or more spinal motion segments. Such connecting elements can provide a rigid construct that resists movement of the spinal motion segment in response to spinal loading or movement of the spinal motion segment by the patient. Other connecting elements can resist loading or movement of the spinal motion segment that creates a tension force on the connecting element; however, the connecting element collapses in response to any compression loading and provides little or no resistance in response to such forces or movement. Still other connecting elements are flexible to permit at least limited spinal motion while providing resistance to loading and motion of the spinal motion segment that is the same in both compression and tension.
While prior connecting elements provide various spinal stabilization options, there remains a need for connecting elements that can provide variable resistance properties to forces and motion in different directions along the spinal motion segment for dynamic stabilization.
The present invention generally relates to devices and methods for dynamically stabilizing a spinal column motion segment including at least two vertebrae.
In one form, a spinal stabilization system includes first and second anchor assemblies engageable to respective ones of first and second vertebral bodies and an elongated connecting element including opposite first and second anchor engaging portions and a length along a longitudinal axis between the first and second anchor engaging portions sized for positioning between and engaging each of said first and second anchor assemblies when the first and second anchor assemblies are engaged to the respective vertebral bodies. The connecting element further includes a support portion between the first and second anchor engaging portions. The support portion includes first and second support members spaced from one another on opposite sides of the longitudinal axis. A stabilizer member extends between and is engaged to the support members in a transverse orientation to the longitudinal axis.
In another form, a connecting element for a spinal stabilization system includes opposite end portions lying along a longitudinal axis and first and second support members diverging relative to one another from the first end portion to respective ones of first and second apexes of the first and second support members. The first and second support members further converge relative to one another toward the longitudinal axis from the respective apex to the second end portion. The connecting element also includes a stabilizer member extending between the first and second apexes.
In another form, a connecting element for a spinal stabilization system includes opposite end portions lying along a longitudinal axis that are spaced for engagement with first and second vertebral bodies of the a spinal column. The connecting element also includes a support portion providing a spring with a hoop-like form extending between the first and second anchor engaging portions and a stabilizer member extending through the support portion between opposite sides thereof in a transverse orientation to the longitudinal axis.
In yet another form, a method for stabilizing a spinal column segment comprises: engaging a first anchor to a first vertebral body of the spinal column; engaging a second anchor to a second vertebral body of the spinal column; engaging a connecting element between the first and second anchors, the connecting element including a support portion including first and second support members extending between opposite end portions of the connecting element along a longitudinal axis, the first and second support members defining a window therebetween along the longitudinal axis; and resisting movement of the first and second support members away from the longitudinal axis in response to compression of the support portion with a stabilizer member in the window.
These and other aspects will be discussed further below.
For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any such alterations and further modifications in the illustrated devices, and such further applications of the principles of the invention as illustrated herein are contemplated as would normally occur to one skilled in the art to which the invention relates.
Devices and methods for providing dynamic stabilization of one or more spinal motion segments are provided. The devices and methods include a connecting element between bone anchor assemblies that can be engaged to at least two vertebral bodies of a spinal motion segment. The connecting element extends along a longitudinal axis and includes end portions engageable to respective ones of the anchor assemblies and a support portion between the end portions. The support portion can include first and second support members extending along opposite sides of and laterally offset from the longitudinal axis and at least one stabilizer member extending transversely to the longitudinal axis to connect the first and second support members.
The stabilizer member can extend transversely to the longitudinal axis and engage the first and second support members at apexes of the first and second support members. The support members can form a hoop or ring type form of any shape where the apexes of the support members are offset from the longitudinal axis. The support members converge toward one another and the longitudinal axis in each of the directions from the apexes where they are joined with the respective end portion.
The anchor assemblies discussed herein can be multi-axial or uni-axial in form, and can include an anchor member engageable to a vertebral body and a receiver, post or other device for receiving or engaging a respective end portion of the connecting element. The multi-axial anchor assemblies allow the anchor member to be positioned at various angles relative to the connecting element engaging portion of the anchor assembly. The uni-axial anchor assemblies can also provide a fixed positioning of the connecting element engaging portion to the anchor member. The anchor member of the anchor assemblies can form a distal lower portion that is engageable to a vertebral body with the proximal connecting element engaging portion positioned adjacent the vertebral body. In one embodiment, the anchor member is in the form of a bone screw with a threaded shaft and a proximal head that is pivotally captured in the receiver. In other embodiments, the distal anchor member can be in the form of a hook, staple, cable, tether, suture anchor, interbody fusion implant, artificial disc implant, bolt, or other structure engageable to bony tissue. The implant engaging portion can include a receiver that defines a passage that receives the respective end portion of the connecting element therein, thereon, therethrough, or thereover, for example. The connecting element can extend from one or both of the anchor assemblies for securement to one or more additional vertebral bodies.
Support portion 48 extends between end portions 44, 46 and provides a hoop-type form with first support member 50 and second support member 52. Support members 50, 52 bifurcate at the respective end portions 44, 46 and extend along and are angularly oriented relative longitudinal axis L on opposite sides thereof. Support members 50, 52 can have oppositely bowed, angular or arc shape such that each forms an apex 54, 56, respectively, at or about the mid-length of the support member along longitudinal axis L that is laterally offset from longitudinal axis L. In order to form the apexes 54, 56, support members 50, 52 diverge arcuately and/or linearly from one another and longitudinal axis L from end portion 44 toward end portion 46 to the respective apex 54, 56. Support members 50, 52 then converge arcuately and/or linearly from the respective apex 54, 56 to the opposite end portion 46.
Support portion 48 defines a window between support members 50, 52 that can have any one of a number of shapes. Window 58 can be oval, circular, diamond, polygonal, or irregular in shape in order to provide support portion 48 with a hoop-type form that provides a spring-like mechanism to facilitate flexing of support members 50, 52 transversely to longitudinal axis L in response to tension and compression loads along longitudinal axis L.
Connecting element 40 further includes a stabilizer member 60 in support portion 48 that extends between and interconnects support members 50, 52. Stabilizer member 60 extends transversely to longitudinal axis L and is engaged at opposite ends thereof to a respective one of the support members 50, 52. In one embodiment, stabilizer member 60 extends through holes in the support members 50, 52 and includes a coupling member 62 engaged to each end thereof that retains and prevents passage of the stabilizer member 60 through the respective adjacent holes in support members 50, 52.
Other embodiments contemplate other devices for securing stabilizer member 60 to the respective support members 50, 52. For example, in
Referring back to
Stabilizer member 60 provides connecting element 40 with an asymmetrical stiffness in compression and tension since stabilizer member 60 is activated to resist loading when support portion 48 is sufficiently compressed to flex support members 50, 52 away from one another, but slackens in response to movement of support members 50, 52 toward one another under tension loading of connecting element 40. Support portion 48 can be resilient so that it returns toward and is normally biased to return to or toward its shape in the neutral condition.
Stabilizer member 160 can be configured to provide some resistance to movement of support members 150, 152 toward one another, but slackens or buckles when a threshold tension force is achieved. Alternatively, stabilizer member 160 can slacken and provide no resistance when activated as a result of axial tension forces.
Stabilizer members 60, 160 can provide the connecting element with a stiffness that provides less resistance to spinal motion that creates axial tension loading, yet can provide greater resistance to spinal motion that creates axial compression loading. Accordingly, spinal motion can be preserved while more effectively limiting compression or movement of the adjacent vertebral bodies toward one another, which may be less desirable in certain treatment conditions.
The connecting elements can resist motion in two directions along the longitudinal axis L while providing a differing stiffness in each of the two directions. The support portion can provide a spring-type mechanism, and the stabilizer member can increase the stiffness of the connecting element at least when the connecting element is compressed. The stabilizer member can be pliable to slacken when the connecting element is tensioned, but strong enough to resist bulging of the support portion when the connecting element is in compression. The stabilizer member and support portion cooperate to provide differing mechanical properties in differing modes of loading and/or motion of the connecting element.
Other embodiments contemplate other arrangements for the stabilizer member relative to the support members and the longitudinal axis in lieu of or in addition to the arrangements discussed above. For example, one or more additional or alternative stabilizers can extend between angled portions of the support members above and/or below any stabilizer member that extends between the apexes of the support members. In another example, a pair of stabilizers could be provided that extend diagonally relative to one another and engage the support members above and/or below the respective apexes. The diagonal stabilizer members can provide increased stiffness to resist torsional or rotational forces created by spinal rotation. In another embodiment, the stabilizer member extends along the longitudinal axis between the end portions of the connecting element to provide increased stiffness to resist axial tension forces while slackening or buckling in response to compression forces that compress the support portion between the end portions of the connecting element.
The connecting element and/or stabilizer member can be made from nitinol, titanium, stainless steel, or other biocompatible metals and alloys thereof. The connecting element and stabilizing member can also be made from PEEK or other polymer material that is biocompatible. The stabilizer member can be made from a material that is the same as or that differs from the material of the connecting element. The stabilizer member can be a rod, cord, rope, wire, tether, belt, band, ribbon, braid, suture, bar, or include any other suitable form. The stabilizer member can be unitary and integral with the connecting element, or can be a separate component attached thereto.
While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that all changes and modifications that come within the spirit of the invention are desired to be protected.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US4361141||Jul 27, 1979||Nov 30, 1982||Zimmer Usa, Inc.||Scoliosis transverse traction assembly|
|US4771767||Feb 3, 1986||Sep 20, 1988||Acromed Corporation||Apparatus and method for maintaining vertebrae in a desired relationship|
|US4854304||Mar 15, 1988||Aug 8, 1989||Oscobal Ag||Implant for the operative correction of spinal deformity|
|US5154718||May 14, 1992||Oct 13, 1992||Zimmer, Inc.||Spinal coupler assembly|
|US5217461||Feb 20, 1992||Jun 8, 1993||Acromed Corporation||Apparatus for maintaining vertebrae in a desired spatial relationship|
|US5330472||Jun 13, 1991||Jul 19, 1994||Howmedica Gmbh||Device for applying a tensional force between vertebrae of the human vertebral column|
|US5330474||Jul 29, 1993||Jul 19, 1994||Lin Chih I||Vertebral locking and retrieving system|
|US5336223||Feb 4, 1993||Aug 9, 1994||Rogers Charles L||Telescoping spinal fixator|
|US5403314||Feb 5, 1993||Apr 4, 1995||Acromed Corporation||Apparatus for retaining spinal elements in a desired spatial relationship|
|US5425732||Jan 13, 1993||Jun 20, 1995||Ulrich; Heinrich||Implant for internal fixation, particularly spondylodesis implant|
|US5486174||Feb 23, 1994||Jan 23, 1996||Soprane S.A.||Fastener for the osteosynthesis of the spinal column|
|US5540688||Mar 8, 1994||Jul 30, 1996||Societe "Psi"||Intervertebral stabilization device incorporating dampers|
|US5562660||Feb 2, 1994||Oct 8, 1996||Plus Endoprothetik Ag||Apparatus for stiffening and/or correcting the vertebral column|
|US5575790||Mar 28, 1995||Nov 19, 1996||Rensselaer Polytechnic Institute||Shape memory alloy internal linear actuator for use in orthopedic correction|
|US5593408||Nov 30, 1994||Jan 14, 1997||Sofamor S.N.C||Vertebral instrumentation rod|
|US5630816||May 1, 1995||May 20, 1997||Kambin; Parviz||Double barrel spinal fixation system and method|
|US5704936||Apr 9, 1993||Jan 6, 1998||Eurosurgical||Spinal osteosynthesis device|
|US5725582 *||Aug 18, 1993||Mar 10, 1998||Surgicraft Limited||Surgical implants|
|US6099528||May 28, 1998||Aug 8, 2000||Sofamor S.N.C.||Vertebral rod for spinal osteosynthesis instrumentation and osteosynthesis instrumentation, including said rod|
|US6102912||May 28, 1998||Aug 15, 2000||Sofamor S.N.C.||Vertebral rod of constant section for spinal osteosynthesis instrumentations|
|US6162223 *||Apr 9, 1999||Dec 19, 2000||Smith & Nephew, Inc.||Dynamic wrist fixation apparatus for early joint motion in distal radius fractures|
|US6241730 *||Nov 27, 1998||Jun 5, 2001||Scient'x (Societe A Responsabilite Limitee)||Intervertebral link device capable of axial and angular displacement|
|US6248106 *||Feb 25, 2000||Jun 19, 2001||Bret Ferree||Cross-coupled vertebral stabilizers|
|US6296644||Feb 25, 2000||Oct 2, 2001||Jean Saurat||Spinal instrumentation system with articulated modules|
|US6440169 *||Jan 27, 1999||Aug 27, 2002||Dimso||Interspinous stabilizer to be fixed to spinous processes of two vertebrae|
|US6626944 *||Feb 19, 1999||Sep 30, 2003||Jean Taylor||Interspinous prosthesis|
|US6761720 *||Oct 13, 2000||Jul 13, 2004||Spine Next||Intervertebral implant|
|US6802844||Mar 25, 2002||Oct 12, 2004||Nuvasive, Inc||Spinal alignment apparatus and methods|
|US6966910 *||Apr 4, 2003||Nov 22, 2005||Stephen Ritland||Dynamic fixation device and method of use|
|US7297146 *||Jan 30, 2004||Nov 20, 2007||Warsaw Orthopedic, Inc.||Orthopedic distraction implants and techniques|
|US7442208 *||Feb 20, 2004||Oct 28, 2008||Synthes (U.S.A.)||Interspinal prosthesis|
|US7520887 *||Feb 17, 2004||Apr 21, 2009||Warsaw Orthopedic, Inc.||Interspinous device for impeding the movements of two successive vertebrae, and method for making a pad designed for it|
|US7524324 *||Dec 3, 2004||Apr 28, 2009||Kyphon Sarl||System and method for an interspinous process implant as a supplement to a spine stabilization implant|
|US7553320 *||Dec 10, 2003||Jun 30, 2009||Warsaw Orthopedic, Inc.||Method and apparatus for replacing the function of facet joints|
|US7585316 *||May 21, 2004||Sep 8, 2009||Warsaw Orthopedic, Inc.||Interspinous spacer|
|US7641673 *||Jul 25, 2001||Jan 5, 2010||Zimmer Spine, S.A.S.||Flexible linking piece for stabilising the spine|
|US20020133155||May 21, 2002||Sep 19, 2002||Ferree Bret A.||Cross-coupled vertebral stabilizers incorporating spinal motion restriction|
|US20030093078||Sep 30, 2002||May 15, 2003||Stephen Ritland||Connection rod for screw or hook polyaxial system and method of use|
|US20030171749 *||Jul 25, 2001||Sep 11, 2003||Regis Le Couedic||Semirigid linking piece for stabilizing the spine|
|US20030191470 *||Apr 4, 2003||Oct 9, 2003||Stephen Ritland||Dynamic fixation device and method of use|
|US20040002708 *||May 8, 2003||Jan 1, 2004||Stephen Ritland||Dynamic fixation device and method of use|
|US20040049189||Jul 25, 2001||Mar 11, 2004||Regis Le Couedic||Flexible linking piece for stabilising the spine|
|US20040049190||Aug 7, 2003||Mar 11, 2004||Biedermann Motech Gmbh||Dynamic stabilization device for bones, in particular for vertebrae|
|US20040073215||Mar 25, 2003||Apr 15, 2004||Scient ' X||Dynamic intervertebral connection device with controlled multidirectional deflection|
|US20040143264||Aug 21, 2003||Jul 22, 2004||Mcafee Paul C.||Metal-backed UHMWPE rod sleeve system preserving spinal motion|
|US20040215191||Apr 22, 2004||Oct 28, 2004||Kitchen Michael S.||Spinal curvature correction device|
|US20040215192||May 19, 2004||Oct 28, 2004||Justis Jeff R||Superelastic spinal stabilization system and method|
|US20050010220||Apr 21, 2004||Jan 13, 2005||Simon Casutt||Instrument system for pedicle screws|
|US20050131407||Dec 16, 2003||Jun 16, 2005||Sicvol Christopher W.||Flexible spinal fixation elements|
|US20050171539 *||Jan 30, 2004||Aug 4, 2005||Braun John T.||Orthopedic distraction implants and techniques|
|US20050182401||Dec 31, 2004||Aug 18, 2005||Timm Jens P.||Systems and methods for spine stabilization including a dynamic junction|
|US20050203514||Dec 27, 2004||Sep 15, 2005||Tae-Ahn Jahng||Adjustable spinal stabilization system|
|US20050203519||Mar 8, 2005||Sep 15, 2005||Jurgen Harms||Rod-like element for application in spinal or trauma surgery, and stabilization device with such a rod-like element|
|US20050261685||Jan 18, 2004||Nov 24, 2005||Frederic Fortin||Flexible vertebral linking device|
|US20050277922||Jun 9, 2004||Dec 15, 2005||Trieu Hai H||Systems and methods for flexible spinal stabilization|
|US20050288672||Sep 1, 2005||Dec 29, 2005||Nuvasive, Inc.||Devices to prevent spinal extension|
|US20060009768||Sep 9, 2005||Jan 12, 2006||Stephen Ritland||Dynamic fixation device and method of use|
|US20060036240||Aug 9, 2004||Feb 16, 2006||Innovative Spinal Technologies||System and method for dynamic skeletal stabilization|
|US20060084994||Nov 22, 2005||Apr 20, 2006||Anulex Technologies, Inc.||Devices and methods for the treatment of spinal disorders|
|US20060106381||Feb 4, 2005||May 18, 2006||Ferree Bret A||Methods and apparatus for treating spinal stenosis|
|US20060129239 *||Dec 13, 2004||Jun 15, 2006||Kwak Seungkyu D||Artificial facet joint device having a compression spring|
|US20060149238||Jan 4, 2005||Jul 6, 2006||Sherman Michael C||Systems and methods for spinal stabilization with flexible elements|
|US20060184171 *||Nov 15, 2005||Aug 17, 2006||Lutz Biedermann||Flexible element for use in a stabilization device for bones or vertebrae|
|US20060229608 *||Mar 17, 2005||Oct 12, 2006||Foster Thomas A||Apparatus and methods for spinal implant with dynamic stabilization system|
|US20070016193 *||Jun 22, 2006||Jan 18, 2007||Stephen Ritland||Dynamic fixation device and method of use|
|US20070073289 *||Sep 27, 2005||Mar 29, 2007||Depuy Spine, Inc.||Posterior dynamic stabilization systems and methods|
|US20070233074 *||Mar 16, 2006||Oct 4, 2007||Sdgi Holdings, Inc.||Expandable device for insertion between anatomical structures and a procedure utilizing same|
|EP0612507A1||Feb 22, 1994||Aug 31, 1994||Societe De Fabrication De Materiel Orthopedique Sofamor||Fixator for osteosynthesis of the lumbosacral spine|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US8308770 *||Sep 22, 2006||Nov 13, 2012||Depuy Spine, Inc.||Dynamic stabilization system|
|US8613760||Dec 14, 2011||Dec 24, 2013||Roger P. Jackson||Dynamic stabilization connecting member with slitted core and outer sleeve|
|US8979904||Sep 7, 2012||Mar 17, 2015||Roger P Jackson||Connecting member with tensioned cord, low profile rigid sleeve and spacer with torsion control|
|US9216041||Feb 8, 2012||Dec 22, 2015||Roger P. Jackson||Spinal connecting members with tensioned cords and rigid sleeves for engaging compression inserts|
|US20080097434 *||Sep 22, 2006||Apr 24, 2008||Missoum Moumene||Dynamic Stabilization System|
|U.S. Classification||606/257, 606/70, 606/246|
|International Classification||A61B17/56, A61B17/70|
|Cooperative Classification||A61B17/7011, A61B17/562|
|European Classification||A61B17/70B1G, A61B17/56J|
|May 8, 2006||AS||Assignment|
Owner name: SDGI HOLDINGS, INC., DELAWARE
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BRUNEAU, AURELIAN;CARLS, THOMAS;LANGE, ERIC C.;AND OTHERS;REEL/FRAME:017877/0130;SIGNING DATES FROM 20060414 TO 20060419
Owner name: SDGI HOLDINGS, INC., DELAWARE
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BRUNEAU, AURELIAN;CARLS, THOMAS;LANGE, ERIC C.;AND OTHERS;SIGNING DATES FROM 20060414 TO 20060419;REEL/FRAME:017877/0130
|Mar 27, 2009||AS||Assignment|
Owner name: WARSAW ORTHOPEDIC, INC., INDIANA
Free format text: MERGER;ASSIGNOR:SDGI HOLDING, INC.;REEL/FRAME:022471/0137
Effective date: 20060428
Owner name: WARSAW ORTHOPEDIC, INC.,INDIANA
Free format text: MERGER;ASSIGNOR:SDGI HOLDING, INC.;REEL/FRAME:022471/0137
Effective date: 20060428
|Apr 17, 2015||REMI||Maintenance fee reminder mailed|
|Sep 6, 2015||LAPS||Lapse for failure to pay maintenance fees|
|Oct 27, 2015||FP||Expired due to failure to pay maintenance fee|
Effective date: 20150906